The European Medicines Agency (EMA) and the American Drug Agency (FDA, for its acronym in English) have advocated, in a workshop held under the umbrella of the International Coalition of Medicines Regulatory Authorities (ICMRA, for its acronym in English), to carry out studies of andeffectiveness of current vaccines against the new variants of the coronavirus.
In the meeting, in which the World Health Organization (WHO), the agencies have assured that the approved Covid-19 vaccines continue to offer protection against the most serious forms of the disease, hospitalization and death, for which they have highlighted the importance of administering it both as a primary dose and as a booster.
However, the agencies have recognized that the continued evolution of the coronavirus reduces the effectiveness of vaccines. “The Ómicron sub-variants, BA.4 and BA.5, are taking over in many parts of the world and experience has already shown that new variants can quickly emerge and replace those currently in circulation,” they said.
At this point, the agencies have reported that preliminary data indicate that adapted mRNA vaccines, incorporating a variant strain of Omicron, may increase and broaden protection when used as a booster. Furthermore, according to preliminary data, a bivalent mRNA vaccine targeting two coronavirus strains, one of which should be an Ómicron one, may provide vAdvantages to amplify the immune response.
“Bivalent vaccines could initially considered for use as reinforcements, and its use for primary vaccination could be supported in the future when more data become available. Likewise, vaccines that include other variants, such as beta, could also be considered as boosters if data from clinical trials demonstrate an adequate level of neutralization against Omicron and other variants of concern.”
now still evidence is being collectedTherefore, regulatory agencies have stressed the need to “carefully” review the clinical data that is being obtained from ongoing clinical trials to determine the suitability of adapted vaccines. Similarly, they have advised planning effectiveness studies with vaccines adapted for determine the level of protection conferred against infection, hospitalization and death.
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